Iuvit D3 Max

Package Leaflet: Information for the Patient

JUVIT D MAX

20,000 IU/ml, Oral Drops, Solution

Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is JUVIT D MAX and what is it used for
• 2. Important information before taking JUVIT D MAX
• 3. How to take JUVIT D MAX
• 4. Possible side effects
• 5. How to store JUVIT D MAX
• 6. Contents of the pack and other information

1. What is JUVIT D MAX and what is it used for

JUVIT D MAX contains vitamin D (cholecalciferol). Vitamin D belongs to the group of

• D vitamins. In the human body, it is converted into active forms, which act as hormones. Cholecalciferol is produced in the human body in the skin under the influence of ultraviolet light (UV rays). Skin synthesis covers only a small part of the demand. The main source of vitamin D is food (meat, milk, egg yolks). The basic property of vitamin D metabolites is to increase the absorption of calcium and phosphates. Vitamin D, by stimulating the production of specific protein in the intestine, facilitates the binding and subsequent transport of calcium to the blood. Cholecalciferol also increases the absorption of calcium and phosphates in the kidneys. In bones, it increases the activity of osteoclasts (cells that remove old bone cells) and osteoclastic osteolysis (the process of bone dissolution under the influence of osteoclasts). All these actions lead to an increase in calcium levels in the blood and the stimulation of proper bone formation and mineralization. Vitamin D is well absorbed in the small intestine after oral administration. Bile acids play an essential role in the absorption process. Cholecalciferol and its metabolites are stored in the liver, fatty tissue, and muscles, from where they are gradually released. They are mainly excreted with bile in combination with glucuronic acid, glycine, and taurine, and in small amounts in urine. Small amounts of cholecalciferol pass into breast milk and through the placenta.

JUVIT D MAX is recommended for use in:

• prevention of vitamin D deficiency and conditions resulting from deficiency (e.g., rickets, osteomalacia) in adults, adolescents, children, infants, and newborns,
• supportive treatment of osteoporosis in adults,
• prevention of vitamin D deficiency in women planning pregnancy, pregnant, and breastfeeding, in agreement with a doctor.

The medicine may be used to treat vitamin D deficiency, rickets, osteomalacia in patients previously diagnosed, as a continuation of treatment.
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2. Important information before taking JUVIT D MAX

When not to take JUVIT D MAX:

Warnings and precautions

Before starting to take JUVIT D MAX, discuss it with your doctor or pharmacist.
Prophylactic dosing of vitamin D in the general population should be individualized depending on age, body weight, sun exposure (season), diet, and lifestyle. In healthy individuals exposed to the sun with uncovered forearms and lower legs for at least 15 minutes between 10:00 and 15:00, without sunscreen, from May to September, supplementation is not necessary, although it is still recommended and safe. If these conditions are not met, supplementation is recommended depending on age, body weight, and vitamin D intake in the diet, throughout the year.
Vitamin D deficiency is defined as a serum level of 25-hydroxycholecalciferol (25(OH)D) <20 ng ml (< 50 nmol l). the target level for optimal vitamin d activity is defined as 30-50 (75-125 l).
If JUVIT D MAX is taken with other medicines or food products containing vitamin D (e.g., combined vitamin and mineral preparations), it may lead to overdose.
During long-term use of vitamin D or in doses greater than 1000 IU per day, calcium levels in the blood should be monitored.
In patients with sarcoidosis, there is a risk of excessive conversion of cholecalciferol to active metabolites. If necessary, doses should be reduced, and patients should be closely monitored for calcium levels in the blood and urine.

JUVIT D MAX and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concomitant use with certain diuretics, e.g., chlorothiazide, increases the risk of hypercalcemia. When taking calcium-containing medicines, monitor calcium levels in the blood. Some antiepileptic medicines (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) may increase the need for vitamin D. Cholestyramine, colestipol, or neomycin may decrease vitamin D absorption. Concomitant administration of vitamin D with cardiac glycosides may enhance their toxic effects (increased risk of arrhythmias). Glucocorticosteroids may weaken the effect of vitamin D.

JUVIT D MAX with food and drink

JUVIT D MAX can be taken with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
The medicine should be used during pregnancy and breastfeeding only in agreement with a doctor.
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Vitamin D and its metabolites pass into breast milk. No overdose has been observed in breastfed children. Breastfed infants require additional vitamin D supplementation.

Driving and using machines

Cholecalciferol is considered a safe medicine that does not impair psychophysical abilities.
JUVIT D MAX does not affect the ability to drive and use machines.

3. How to take JUVIT D MAX

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The medicine is intended for oral use.
Prevention of vitamin D deficiency and conditions resulting from deficiency (e.g., rickets, osteomalacia) in adults, adolescents, children, infants, and newborns:
For newborns and infants, the medicine should be used under medical supervision.
The most commonly used dosing regimen:
Preterm infants: 1-2 drops (500-1000 IU) per day. After reaching 40 weeks of corrected age, the prophylactic dose should be reduced. The dosage must be determined by the attending physician.
Newborns and infants up to 12 months: 1 drop (500 IU) per day.
Children from 1 to 10 years: if sufficient sun exposure is not possible, 1-2 drops (500-1000 IU) per day.
Children from 11 years, adolescents, and adults: if sufficient sun exposure is not possible, 2-4 drops (1000-2000 IU) per day.
Older adults (over 75 years): 4-8 drops (2000-4000 IU) per day.
Supportive treatment of osteoporosis in adults:
2-4 drops (1000-2000 IU) per day.
Prevention of vitamin D deficiency in women planning pregnancy, pregnant, and breastfeeding, in agreement with a doctor:
Usually, the recommended dose is 4 drops (2000 IU) per day, unless the doctor recommends a different dosing regimen. During pregnancy, women should follow the doctor's recommendations, as the need for vitamin D may vary depending on their body's resources.
Patients with renal impairment
In patients with renal failure, calcium and phosphate metabolism should be monitored. In case of hypercalcemia or signs of renal impairment, the dose should be reduced or treatment discontinued. It is recommended to reduce the dose or discontinue treatment if the daily excretion of calcium in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
The medicine should not be used for a long time or in higher doses without medical supervision. Additionally, without medical supervision, do not take other medicines, dietary supplements, or other food products containing vitamin D (cholecalciferol), calcitriol, or other metabolites and analogs of vitamin D.
For infants and young children, the medicine can be administered on a spoon with a drink or food.
Due to the risk of overdose, do not administer the medicine directly from the bottle to the patient's mouth.
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Overdose of JUVIT D MAX

In case of taking a higher dose than recommended, consult your doctor or pharmacist immediately.
Signs of poisoning occur rarely and appear after administration of 10,000 IU of vitamin D (0.25 mg) per day. Such doses may cause weakness, hypercalcemia, apathy, loss of appetite, headache, muscle and joint pain, muscle weakness, nausea, vomiting, ectopic calcification of tissues, proteinuria, hypertension, and arrhythmia. Chronic hypercalcemia leads to calcification of blood vessels and kidneys and a significant deterioration of kidney function. In such cases, the medicine should be discontinued. Hospitalization, symptomatic treatment, and calcium removal may be necessary. There is no specific antidote.

Missed dose of JUVIT D MAX

Do not take a double dose to make up for a missed dose.

Stopping JUVIT D MAX

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, JUVIT D MAX can cause side effects, although not everybody gets them.
Side effects do not occur when taken in recommended doses.
Taking vitamin D in higher doses causes hypervitaminosis and hypercalcemia and related symptoms:
Common (from 1 to 10 patients in 100 cases):

• hypercalcemia, hypercalciuria.

Frequency not known (frequency cannot be estimated from available data):

• heart muscle damage, arrhythmias,
• anemia, calcification of blood vessels,
• headache, seizures,
• loss of appetite, abdominal pain, bloating, nausea, vomiting, diarrhea, or constipation,
• kidney damage, polyuria,
• muscle and joint pain,
• ectopic calcifications,
• conjunctivitis,
• hypersensitivity reactions, such as: skin itching, rash, or urticaria.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store JUVIT D MAX

Keep the medicine out of sight and reach of children.
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There are no special recommendations for storing the medicine at a certain temperature. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Once opened, the bottle should be used within 12 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What JUVIT D MAX contains

• The active substance is cholecalciferol in the amount of 0.5 mg (20,000 IU) in 1 ml of solution (1 ml of solution contains 40 drops).
• The other ingredients (excipients) are: triglycerides of fatty acids of medium chain length.

What JUVIT D MAX looks like and contents of the pack

The medicine is a colorless or yellowish, clear solution (opacity is allowed), odorless.
The packaging consists of a 10 ml glass bottle, type III, closed with an HDPE cap with an LDPE dropper; the bottle is labeled and placed together with the patient leaflet in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
phone: +48 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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